CoRoent 6791712
CoRoent 6791712 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K231735 on 11 Jul 2023 (5 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887517362094), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231735 | Date11 Jul 2023 | StatusActive |
| United States | GUDID listing | Number00887517362094 | Date24 Oct 2015 | StatusListed |
Official records
- AccessGUDID record 00887517362094
- FDA 510(k) database K231735
- FDA 510(k) database K192582
- FDA 510(k) database K170961
- FDA 510(k) database K161442
- FDA 510(k) database K142299
- FDA 510(k) database K102547
Across registries
- FDA 510(k) K231735 decided 11 Jul 2023 Active
- FDA GUDID UDI-DI 00887517362094 listed 24 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K102547
- Cleared FDA 510(k) K142299
- Listed FDA GUDID 00887517362094
- Cleared FDA 510(k) K161442
- Cleared FDA 510(k) K170961
- Cleared FDA 510(k) K192582
- Cleared FDA 510(k) K231735
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CoRoent
- Generic name
- Polymeric spinal interbody fusion cage
- Model / reference
- 6791712
- Primary DI / UDI-DI
- 00887517362094
- FDA product code
- ODP, OVE
- GMDN term
- Polymeric spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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